J&J Acquires Phase III Antibiotic Doripenem; NDA Possible In 2006

Johnson & Johnson is acquiring the Phase III injectable carbapenem antibiotic doripenem via its $245 mil. purchase of Peninsula Pharmaceuticals.

Peninsula is conducting six Phase III trials for doripenem in indications including urinary tract infections (including pyelonephritis), complicated intra-abdominal infections and hospital-acquired pneumonia (including ventilator-associated pneumonia).

In an initial public offering registration statement filed in January, Peninsula said its goal was to file an NDA for doripenem in 2006. Doripenem has a fast-track designation from FDA for the ventilator-associated pneumonia indication; no antibiotics are approved for that population.

"Ventilator-associated pneumonia is the most common intensive care unit-acquired infection and occurs in 8% to 28% of patients mechanically ventilated for more than 48 hours," Peninsula said in the IPO filing.

"A recent study suggests that the development of ventilator-associated pneumonia was associated with an increase of $40,000 in mean hospital charges per patient. The mortality rate attributable to ventilator-associated pneumonia ranges from 24% to 50%, but can reach 76% in some specific settings or when lung infection is caused by high-risk pathogens such as P. aeruginosa."

Alameda, Calif.-based Peninsula was founded in 2001. The company licensed North American rights to doripenem from the Japanese firm Shionogi in 2002.

J&J is paying $245 mil. in cash for Peninsula; the deal is expected to close in the second quarter. Although the transaction is technically a merger, the outcome will be closer to a product purchase agreement. Peninsula's other research project, the cephalosporin antibiotic PPI-0903, will be spun off into a new company named Cerexa, Inc.

J&J already has a cephalosporin candidate in Phase III: ceftobiprole (BAL5788), licensed from Basilea. J&J's currently marketed anti-infectives include the quinolone antibiotic Levaquin .

J&J is buying Peninsula for about a 50% premium to its projected value at the time of the IPO filing, and the company is paying about triple the $80 mil. paid-in-capital of Peninsula's investors.

Shionogi owns a 19% equity stake in Peninsula and so will receive $47 mil. in the deal. Peninsula's agreement with Shionogi calls for the Japanese firm to manufacture the antibiotic and be compensated at a fixed price per unit. Shionogi also has rights to the Phase III data for use in pursuing registration in other markets.

The basic compound patent on doripenem runs until August 2012; however, Peninsula said, it has also licensed a pending Shionogi patent claiming "a particular crystal polymorph with enhanced stability and methods for producing such crystal polymorph. This polymorph is an active ingredient in all doripenem products sold."

Peninsula believes that doripenem's stability profile is one potentially unique property that makes the compound attractive for development (see chart: " ¹ Doripenem's Attributes ").